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O estudo clínico NCT06848335 (Seamos Activas) para Inactivity, Inatividade/baixos níveis de exercício, Inatividade física está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Improving Physical Activity Participation in Latinas With Mindfulness (Seamos Activas)
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06848335 (Seamos Activas) é um ensaio intervencionista para Inactivity, Inatividade/baixos níveis de exercício, Inatividade física. Seu status atual é: recrutando. O estudo começou em 21 de março de 2025 e pretende incluir 258 participantes. Coordenado por Bess Marcus e deve ser concluído em 31 de julho de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 25 de abril de 2025.
Resumo
In this study, the investigators are exploring how a mindfulness-based physical activity program can help improve exercise habits and overall health among 258 inactive Latina women aged 18 to 65. The study will be conducted entirely remotely over and 18 month period. During the first 6 months, all participants will receive an exercise program that has previously been tested by our research team. After 6 months, the investigators will check if participants are meeting the recommended exercise guidelines of at least 150 minutes/week of at least moderate intensity activity. Participants who meet the guidelines will continue with the successful exercise program for another 6 months. For participants who do not meet the guidelines (are exercising less than 150 minutes/week), they will receive one of two enhanced programs, which will be randomly assigned. One program offers additional physical activity support, and the other incorporates stress management through mindfulness techniques. For all participants, over 18 months, the investigators will track physical activity levels, stress, and heart health indicators.
Descrição detalhada
The current study is an innovative adaptive intervention tested on inactive Latinas aged 18-65 (n=258). During the initial 6 month phase, all participants will receive our evidence based physical activity (PA) intervention. At 6 months, participants who meet national PA guidelines (at least 150 mins/week of at least moderate intensity PA) will continue to receive the standard PA intervention for another 6 months. Participants who do not meet the PA guidelines, will be randomized to continue intensive PA counseling or receive attention matched PA counseling incorporating the most potent components from Mindfulness-Based Stress Reduction (MBSR) adapted for PA. Participants in all 3 arms will be followed and compared over 18 months. The investigators will also rigorously evaluate stress as a mechanism for meeting PA guidelines using multiple measures (objective and self-report), including using wearable technology and Ecological Momentary Assessment (EMA). Finally, heart health indicators will be collected to assess long term benefits of PA.
Título oficial
Improving Physical Activity Participation in Latinas With Mindfulness
Condições
InactivityInatividade/baixos níveis de exercícioInatividade físicaOutros IDs do estudo
Número NCT
Data de início (real)
2025-03-21
Última atualização postada
2025-04-25
Data de conclusão (estimada)
2029-07-31
Inscrição (estimada)
258
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
Physical Activity
Latinas
Spanish-Language
Text-Message
Exercise
Mindfulness
Latinas
Spanish-Language
Text-Message
Exercise
Mindfulness
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalRemote Physical Activity Intervention | Remote Physical Activity Intervention The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6, with maintenance doses in months 8 and 10. Mailings include motivation-matched physical activity manuals, tip sheets (on stretching, boredom, places to be active, etc.) and computer expert system-tailored PA feedback reports which draw from a bank of over 330 messages addressing psychosocial and environmental factors affecting PA. Participants receive one interactive text message on PA (goal setting and tips for increasing PA) daily for the first 6 months and weekly for months 7-12. |
Comparador ativoMindfulness Enhanced Remote Physical Activity Intervention | Mindfulness Enhanced Remote Physical Activity Intervention Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Attention Matched Enhanced Remote PA intervention or Mindfulness enhanced remote Physical Activity intervention. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals. For the Mindfulness enhanced remote Physical Activity intervention participants will receive additional messaging and support to manage their stress through incorporating evidence based MBSR and mindful movement into their daily routine. |
Comparador ativoAttention Matched Enhanced Remote Physical Activity Intervention | Attention Matched Enhanced Remote PA Intervention Women who do not meet the PA guidelines (60% based on our prior work), will be randomized to receive the Mindfulness enhanced remote Physical Activity intervention or the Attention Matched Enhanced Remote PA intervention as described here. The intervention includes a Zoom goal setting session on PA at baseline and phone calls at week 1, and months 1, 2, 3, and 9 for new goal setting and to address questions and monitor progress on PA goals. Participants will receive mailings weekly in month 1, bi- weekly in months 2 and 3, and monthly in months 4 to 6. In months 7-12, they will receive 4 monthly calls, 11 mailers and daily texts. In months 13-18, they will receive 1 call, weekly texts to self monitor daily PA and meeting goals. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Accelerometer-measured min/week MVPA | For the week prior to each assessment (baseline, 6, 12, 18-months), all participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure. Data will be used to generate a binary indicator of meeting national PA guidelines (at least 150 min/week MVPA) at each follow-up. | 12 and 18 Months (outcome timepoints) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Perceived Stress Scale(PSS) | Measured using a 14-item Perceived Stress Scale(PSS), this self-report measure assesses general perceptions of demands in life exceeding one's capacities to manage them. This scale has shown good reliability and validity in past studies with Spanish speaking Latino participants. The scale score ranges from 0 to 56, with higher scores indicative of higher perceived stress. | Baseline, 6 months, 12 months, 18 months |
Moment to moment self-reported stress evaluated via Ecological momentary assessment (EMA) | Participants will be prompted daily (via the wake-up report and random prompts) to respond to : How stressed are you feeling right now? Response options are on a 7-point Likert scale ranging from 0=Not at all to 6=Extremely. | Baseline, 6, 9, 12 months |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Feminino
Aceita voluntários saudáveis
Sim
- Female
- Generally healthy (If asthma, controlled high blood pressure and/or controlled type II diabetes, may be able to participate with physician consent)
- Sedentary (defined as participating in MVPA for 60 minutes or less per week and engaging in muscle-strengthening exercise on less than 2 days per week)
- Hispanic or Latina (self-identified)
- Must be able to read and write in Spanish fluently
- 18 - 65 years of age
- Planning on living in the area for the next 18 months
- Own a cell phone capable of sending and receiving text messages
- Required to have reliable access to the Internet via a computer or mobile device
- Must be able to receive materials in the mail, either at your own home or at a mailbox
- BMI greater than 45
- Not able to walk continuously for 30 minutes/limited ability to complete daily activity or ability to exercise
- Exercise is against advice of doctor
- Inability to walk independently
- Current or planned pregnancy in the next 12 months
- Heart disease/treatment
- Heart murmur
- Angina/chest pain or Angina/chest pain with exertion
- Palpitations
- Stroke/Transient Ischemic Attacks
- Peripheral Vascular Disease
- Diabetes that requires insulin
- Non-insulin dependent diabetes without physician approval to participate
- Chronic infectious disease- HIV, Hepatitis C but does not have doctor approval
- Chronic liver disease
- Cystic Fibrosis
- Abnormal EKG on last EKG performed
- Emphysema, Chronic bronchitis, Chronic Obstructive Pulmonary Disease
- Seizure in past year
- Surgery in past year on heart, lung, joint, orthopedic surgery
- Surgery pending in next year on lung, joint, orthopedic surgery
- Unusual/concerning shortness of breath
- Asthma (may be able to participate with physician consent)
- High blood pressure/high blood pressure medication (may be able to participate with physician consent)
- Use of Beta Blockers or medicines not approved by doctor.
- Abnormal Medical Stress Test in the last 12 months
- Musculoskeletal problems
- Fainting/dizziness more than 3 times in past year OR which interferes with daily activities OR causes loss of balance
- Cancer treatment in past 3 months
- Hospitalized for psychiatric disorder in past 3 years or suicidal
- Participation in prior Seamos Activas II study or participant in other research study about exercise currently or within the last 6 months ago
Bess Marcus- Instituto Nacional do Coração, Pulmão e Sangue, EUA759 estudos clínicos ativos para explorar
- Lifespan/ The Miriam Hospital
Responsável pelo estudo
Bess Marcus, Patrocinador-Investigador, Professor of Behavioral and Social Sciences, Brown University
Contato central do estudo
Contato: Bess H Marcus, PhD, (401) 863-6850, [email protected]
Contato: Rachelle Edgar, BS, (401) 863-6850, [email protected]
1 Locais do estudo em 1 países
Rhode Island
Brown University, Providence, Rhode Island, 02912, United States
Rachelle Edgar, BS, Contato, (401) 863-6850, [email protected]
Bess H. Marcus, PhD, Investigador principal
Recrutando